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Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

Primary Purpose

Cirrhosis, Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biannual ultrasonography
Annual noncontrast liver MRI
Contrast enhanced liver CT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cirrhosis focused on measuring MRI, HCC, surveillance

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • equal to or older than 40 years
  • under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
  • risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
  • signed informed consent

Exclusion Criteria:

  • under 40 years
  • history of HCC
  • patients with pregnancy or nursing
  • any contraindication of MRI
  • any contraindication of CT

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LC group

Arm Description

LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.

Outcomes

Primary Outcome Measures

sensitivity for detecting HCC

Secondary Outcome Measures

specificity for detecting HCC

Full Information

First Posted
July 31, 2016
Last Updated
March 16, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02854241
Brief Title
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance
Official Title
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.
Detailed Description
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hepatocellular Carcinoma
Keywords
MRI, HCC, surveillance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LC group
Arm Type
Experimental
Arm Description
LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.
Intervention Type
Procedure
Intervention Name(s)
Biannual ultrasonography
Intervention Description
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
Intervention Type
Procedure
Intervention Name(s)
Annual noncontrast liver MRI
Intervention Description
Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map. DWI using multishot and T2 map are not included for initial MR reading.
Intervention Type
Procedure
Intervention Name(s)
Contrast enhanced liver CT
Intervention Description
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
Primary Outcome Measure Information:
Title
sensitivity for detecting HCC
Time Frame
6 months after last patient's MRI
Secondary Outcome Measure Information:
Title
specificity for detecting HCC
Time Frame
6 months after last patient's MRI
Other Pre-specified Outcome Measures:
Title
Apparent diffusion coefficient (ADC)
Description
calculated value from diffusion weighted image with different protocols (conventional, simultaneous multishot)
Time Frame
1 month after each MR scan
Title
T2 relaxation time
Description
calculated value from T2 map
Time Frame
1 month after MR scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: equal to or older than 40 years under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month) risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)). signed informed consent Exclusion Criteria: under 40 years history of HCC patients with pregnancy or nursing any contraindication of MRI any contraindication of CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

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